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New Research Collaboration with Pharmsynthez

16 November 2009

Six candidates to be clinically validated utilising ImuXen or PolyXen

Lipoxen plc (AIM: LPX), a bio-pharmaceutical company specialising in the development of high-value differentiated biologicals, vaccines and siRNA delivery, is pleased to announce that it has signed a collaboration agreement (the "Agreement") with Pharmasynthez ZAO ("Pharmsynthez"), a leading Russian private research-based pharmaceutical company, to apply Lipoxen's ImuXen and PolyXen proprietary technologies to a broad range of six drug and vaccine candidates in collaboration with Pharmsynthez. Lipoxen will provide scientific supervision to Pharmsynthez for candidate optimisation and clinical proof of concept trials will be funded by Pharmsynthez. Lipoxen will have access to all relevant clinical data arising from the subsequent clinical trials.

Highlights of the Agreement

• Lipoxen's ImuXen and PolyXen platform technologies to be validated across a broad spectrum of six vaccine and drug candidates
• Limited resources required from Lipoxen to achieve human clinical proof of principle, with Pharmsynthez funding subsequent full clinical trial programmes in the Russian Federation.
• Lipoxen will have the right to use all relevant clinical trial data to conduct further trials and seek marketing authorisation in other world territories
• Four product candidates targeting the rare disease indications which could potentially lead to abbreviated clinical pathway and market exclusivity periods under EU and US Orphan Drug legislation.

Under the Agreement, Pharmsynthez will apply Lipoxen's ImuXen technology to create three enhanced vaccine candidates for secondary progressive multiple sclerosis, HIV and non-Hodgkin's lymphoma. Similarly, Lipoxen's PolyXen technology will be applied to active compounds to create three pharmaceutical candidates for treatment of cystic fibrosis, acute myeloid leukaemia, non-Hodgkin's lymphoma and type 2 diabetes.

Scientists from Pharmsynthez will optimise the candidates with guidance from Lipoxen and will complete testing to achieve clinical proof of principle the end of 2010. Candidates that show promise, as determined by a Programme Committee, will then progress to full-scale clinical development in Europe and the United States.

Secondary progressive multiple sclerosis, cystic fibrosis ,non-Hodgkin's lymphoma and acute myeloid leukaemia are all rare diseases and candidates that are progressed for these indications could be eligible for an abbreviated clinical pathway under EMEA and FDA regulations and market exclusivity for ten years and seven years respectively. Lipoxen will have the right to use all relevant data from the clinical trials to conduct further trials and seek marketing authorisation in other world territories.

As a result of the Agreement, Lipoxen will receive royalties of 10% of all net sales from Pharmsynthez should the products progress through clinical development and be approved for marketing in the Russian Federation. A Programme Committee, to be chaired by Lipoxen, will be formed to progress the Agreement which will comprise representatives from both Lipoxen and Pharmsynthez. Any arising intellectual property will be jointly owned by the two parties, unless it relates solely to Lipoxen's platform technologies.

ImuXen is an advanced platform vaccine delivery technology that employs novel liposome constructs to boost the effectiveness of DNA, protein and polysaccharide vaccines. PolyXen is a multifaceted platform technology that employs polysialic acid to prolong the active life of the drug in the body and improve the effectiveness of the drugs.

Commenting on the Agreement, M. Scott Maguire, CEO of Lipoxen, said:

"We are very pleased to be working with Pharmsynthez to apply our ImuXen and PolyXen platform technologies to Pharmsynthez's compounds in multiple sclerosis, HIV and non-Hodgkin lymphoma as well as cystic fibrosis, acute myeloid leukemia and type 2 diabetes. Given that the commitment of upfront resources is limited to sharing our scientific knowledge of our propriety platform technologies, Lipoxen is particularly pleased to have access to the clinical data from these trials which will put it in a strong position to decide whether to run EMEA and FDA trials on the candidates to achieve marketing approval in other world territories.

"In addition, achieving human clinical proof of concept for these products further validates our ImuXen and PolyXen platform technologies and the clinical data produced will support the utility of these broadly applicable technologies to enhance existing propriety compounds, which forms an important part of our business model."

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